Status:
COMPLETED
Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-op Pain in Adult Patients Undergoing Elective Orthopedic Surgery
Lead Sponsor:
YM BioSciences
Conditions:
Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.
Eligibility Criteria
Inclusion
- male and female 18 to 70 years
- patient alert and capable of self-administering an opioid anaglesic
- Patient is scheduled for orthopedic surgery under general anesthesia
- Patient has normal laboratory values
- Physical examination with no clincially relevant findings
- Patient in general good health based on medical history and clincially acceptable
- Patient is able to understand the requirements of the study
- Patient is able to communicate effectively with study personnel \_Patient voluntarily gives written approval.
Exclusion
- During Part 2 (randomized period) which involves the use of placebo, patients who are undergoing a major orthopedic procedure that normally requires multimodal analgesia to achieve adequate postoperative pain control (e.g. major spine surgery, total knee arthoplasty) will be excluded.
- Patient is taking opioid or non-opioid analgesics on a chronic basis at doses which in the opinion of the investigator would interfere with evaluations of post-operative fentanyl efficacy.
- History of pulmonary, cardiovascular, neurologic, endocrine, hepatic, gastrointestinal (GI), or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study.
- Patient has documented or self-reported medical history of sleep apnea.
- Patient has a documented hypersensitivity to fentanyl or other opioid analgesics.
- Patient has a documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation, including hypersensitivity to soya lecithin or related food products such as soya bean and peanut.
- Patient is currently receiving treatment, or has received treatment in the previous two weeks, with monoamine oxidase inhibitors.
- Patient has a history of malignancy within the past 5 years, with the exception of successfully treated non?metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
- Patient was dosed with another investigational drug within 30 days prior to the Screening Visit.
- Patient has current therapy with CNS-depressant medications (other than stable doses of analgesics and drugs used with surgical anesthesia).
- Patient has current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
- Patient has a history of abuse of licit or illicit drug substances.
- Patient, who in the opinion of the Investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00286065
Start Date
January 1 2006
Last Update
June 27 2007
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada